Devices and related methods for securing a tissue fold

ABSTRACT

The present invention relates to devices and methods for creating and securing a tissue fold during an endoluminal medical procedure. The devices and methods may be used for folding and securing, for example, a fundus wall onto an esophagus wall. An aspect of the invention includes a two-piece tissue clip configured to be installed through an endoluminal device to secure a tissue fold. The clip includes a female member and a male member configured to engage one another to secure the tissue fold. Another aspect of the invention includes a clipping device comprising a tissue clip magazine. The magazine is configured to hold a plurality of tissue clips and install the plurality of tissue clips in a single actuation of the magazine. A method for using the clipping device together with the tissue clips of the present invention to create and secure a fold of tissue during an endoluminal procedure also is disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/037,658, filed Mar. 1, 2011, which is a continuation of U.S.application Ser. No. 11/715,966, filed Mar. 9, 2007 (now U.S. Pat.7,918,866), which is a continuation of U.S. application Ser. No.10/419,105, filed Apr. 21, 2003 (now U.S. Pat. No. 7,204,842), which isa continuation of U.S. application Ser. No. 09/568,012, filed May 10,2000 (now U.S. Pat. No. 6,592,596), all of which are incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention pertains to devices, and a method for using thedevices, for creating and securing a tissue fold during an endoluminalprocedure. More specifically, the invention relates to devices andmethods for folding, for example, a region of the stomachcircumferential to the opening of the esophagus back onto the esophagus.

BACKGROUND OF THE INVENTION

Gastroesophageal reflux occurs when stomach acid enters the esophagus.This reflux of acid into the esophagus occurs naturally in healthyindividuals, but also may become a pathological condition in others.Effects from gastroesophageal reflux range from mild to severe. Mildeffects include heartburn, a burning sensation experienced behind thebreastbone. More severe effects include a variety of complications, suchas esophageal erosion, esophageal ulcers, esophageal stricture, abnormalepithelium (e.g., Barrett's esophagus), esophageal cancer, and/orpulmonary aspiration. These various clinical conditions and changes intissue structure that result from reflux of stomach acid into theesophagus are referred to generally as Gastroesophageal Reflux Disease(GERD).

Many mechanisms contribute to prevent gastroesophageal reflux in healthyindividuals. One such mechanism is the functioning of the loweresophageal sphincter (LES). With reference to FIG. 1, the LES is aregion of smooth muscle and increased annular thickness existing in thelast four centimeters of the esophagus. In its resting state, the LEScreates a region of high pressure (approximately 15-30 mm Hg aboveintragastric pressure) at the opening of the esophagus into the stomach.This pressure essentially closes the esophagus so that contents of thestomach cannot pass back into the esophagus. The LES opens in responseto swallowing and peristaltic motion in the esophagus, allowing food topass into the stomach. After opening, however, a properly functioningLES should return to the resting, or closed state. Transient relaxationsof the LES do occur in healthy individuals, however, typically resultingin normal physiological functions such as belching and vomiting.

The physical interaction occurring between the gastric fundus and theesophagus also prevents gastroesophageal reflux. The gastric fundus is alobe of the stomach situated at the top of the stomach proximal to theesophagus. In healthy individuals, the fundus presses against theopening of the esophagus when the stomach is full of food and/or gas.This effectively closes off the esophageal opening to the stomach andhelps to prevent acid reflux back into the esophagus.

In individuals with GERD, the LES functions abnormally, either due to anincrease in transient LES relaxations, decreased muscle tone of the LESduring resting, or an inability of the esophageal tissue to resistinjury or repair itself after injury. More generally, GERD results froma change in the geometrical relationship between the esophagus and thefundus of the stomach. Normally, the fundus extends above the exit ofthe esophagus into the stomach. Thus, as intra-abdominal pressureincreases, the fundus pushes against the LES to assist in closing theLES. In people with GERD, the fundus flattens out so that it no longerassists in closing the fundus. Moreover, the LES tends to shorten fromabout 4 cm to about 2 cm in length. GERD can also be caused by hiatelhernia, which also may potentially lead to a change in the geometricrelationship as described above. These conditions often are exacerbatedby overeating, intake of caffeine, chocolate or fatty foods, and/orsmoking. Avoiding these exacerbating mechanisms helps reduce thenegative side effects associated with GERD, but does not cure thedisease completely.

A surgical procedure, known generally as fundoplication, has beendeveloped to prevent acid reflux in patients whose normal LESfunctioning has been impaired. Fundoplication involves bringing thefundus into closer proximity to the esophagus to help close off theesophageal opening into the stomach. In Nissen Fundoplication, aparticular type of the fundoplication procedure, the fundus is pulled upand around the esophagus and sutured both to itself and to the esophagussuch that it completely encircles the esophagus. Traditionally, thisprocedure has been performed as an open surgery, but has recentlyenjoyed success as a laparoscopic procedure, as discussed in McKernan,J. B., Champion, J. K., “Laparoscopic antireflex surgery,” AmericanSurgeon, Vol. 61, pp. 530-536, (1995).

As with any open surgery, the risks attendant in such a procedure aregreat. Due to relatively large incisions necessary in the performance ofopen surgery, relatively large amounts of blood are lost and risk ofinfection increases. Though laparoscopic surgical procedures reducethese negative effects by using relatively small devices at a relativelysmall incision site in the abdominal wall, there still exists anincreased risk of infection due to the incision. The location of theincision in the abdominal wall presents a risk of other negativeeffects, such as sepsis, which can be caused by leakage of septic fluidcontained in the stomach. Furthermore, as with any surgery, there existsa small risk of morbidity and mortality associated with the use ofgeneral anasthesia.

SUMMARY OF THE INVENTION

The advantages and purpose of the present invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theadvantages and purpose of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

The present invention includes devices, and related methods for usingthe devices, to fold and secure tissue during an endoluminal medicalprocedure. In particular, the inventive devices, and the methods forusing the devices, may be employed in Nipple Fundoplication procedures,a specific type of fundoplication procedure which will be describedshortly, for the treatment of GERD. When used to perform, for example,Nipple Fundoplication, the inventive devices allow the procedure to becompleted rapidly, repeatedly, and consistently without compromisingsafety or increasing invasiveness.

To attain the advantages and in accordance with the purpose of theinvention, as embodied and broadly described herein, the inventionincludes a device for securing a fold of tissue comprising a femalemember and a male member. The female member defines an aperture and themale member has an engaging member configured to pierce and extendthrough a fold of tissue. The the aperture and engaging member areconfigured so as to allow the engaging member to pass through theaperture in a first direction when the female and male members are in adisengaged relationship and to restrict the engaging member from passingthrough the aperture in a second direction opposite to the firstdirection when the female and male members are in an engagedrelationship.

Another aspect of the invention includes a clipping device for creatingand securing a tissue fold. The clipping device includes a tube having amagazine disposed on its distal end. The magazine is configured to holda plurality of tissue clips for installation to secure the tissue fold.An actuator, disposed at a proximal end of the shaft, actuates themagazine to simultaneously install the plurality of tissue clips.

Yet another aspect of the invention includes a method for securing atissue fold during an endoluminal medical procedure. The method includesproviding a plurality of tissue clips configured to engage and secure atissue fold, and providing a tissue clip magazine configured to hold theplurality of tissue clips. The method further includes inserting thetissue clip magazine using an endoluminal procedure into an area of thebody where a tissue fold is to be secured. The magazine is thenpositioned proximal to the tissue fold and actuated such that theplurality of tissue clips are simultaneously installed with respect tothe tissue fold.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate the preferred embodiments of theinvention and, together with the description, serve to explain theprinciples of the invention. In the drawings,

FIG. 1 is a cross-sectional view of the gastrointestinal tract from amid-point of the esophagus to a point near the beginning of theduodenum;

FIG. 2 is a perspective view of a respective female member and malemember that form a tissue clip according to an embodiment of the presentinvention;

FIGS. 3 a-3 c are respective side, front, and rear views of anembodiment of a clipping device according to the present invention;

FIG. 4 is a cross-sectional view taken through plane A-A′ in FIG. 3 bshowing details of the internal structure of the embodiment of theclipping device according to the present invention;

FIG. 5 a is cross-sectional side view of an embodiment of the clippingdevice with tissue clips inserted according to the present invention;

FIG. 5 b is a cross-section view of FIG. 5 a taken through line B-B′;

FIG. 6 is a cross-sectional side view of the clipping device of FIG. 5a, with an upward force exerted on the cable to move a sliding clipholder toward a stationary clip holder;

FIG. 7 is a cross-sectional side view of the clipping device of FIG. 5 aafter the female and male members of the tissue clip have been engagedto secure the tissue fold and the upward force has been released tocause the sliding clip holder to spring back into its original position;

FIG. 8 is a side view of an embodiment of the clipping device of thepresent invention shown inserted into the stomach through the esophaguswith an endoscope fed through the endoscope lumen to provide vision andthe tissue clip magazine shown in position to form the tissue fold ofthe fundus onto the esophagus; and

FIG. 9 is a cross-sectional view of a portion of the esophagus andstomach shown with tissue clips installed in a semi-circular array tosecure the fold of tissue created between the fundus and the esophagus.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

A newly developed form of fundoplication, referred to as NippleFundoplication, is an endoluminal procedure in which the fundus isfolded back onto the esophagus. The tissue fold formed between theesophagus and fundus is then secured. Nipple Fundoplication is intendedto be performed as an endoluminal procedure, with insertion of requiredmedical instruments occurring through the esophagus. Such a procedurehas the benefits of being less invasive, quicker, and less expensive ascompared to previous techniques.

As with most endoluminal procedures, preferably, completion of NippleFundoplication occurs as rapidly as possible without compromising thesafety or non-invasiveness of the procedure. To maintain the procedureas relatively non-invasive, it is preferable to provide a device, andmethod for using the device, that is small in size, yet has thecapability to secure the fundus to the esophagus in a plurality oflocations during a single insertion and with consistent results.

The various aspects of this invention pertain generally to a tissue clipand a clipping device for installing the tissue clip to create andsecure a tissue fold during an endoluminal procedure. The devices, andmethods for their use, are particularly suited for performing the NippleFundoplication procedure described previously. Using the inventivedevices to secure the fundus to the esophagus in Nipple Fundoplicationallows the procedure to be performed rapidly and relativelynon-invasively, and results in a substantially uniform tissue fold.

To accomplish these objectives, the present invention includes a tissueclip and a clipping device adapted to position the tissue clip to securethe fold of tissue created during the endoluminal procedure.Additionally, the present invention includes a method for using thetissue clip and the clipping device. Although, the inventive deviceswill be discussed mainly with reference to their use in securing afundus wall to an esophagus wall in a Nipple Fundoplication procedure,the devices can be used in conjunction with other medical proceduresthat require creating and securing tissue folds. Moreover, the devicesmay be used in other settings, including industrial settings, thatrequire the securing of two surfaces together in an environment havinglimited access to the two surfaces.

A preferred embodiment of a tissue clip 10 according to the presentinvention is shown in FIG. 2. Tissue clip 10 includes two members, afemale member 11 and a male member 12. Members 11 and 12 essentiallyhave plate-shaped configurations, shown as square plates in the Figure.Female member 11 includes an X-shaped aperture 13 disposed substantiallyin the center of the member and extending through its thickness. Malemember 12 includes an engaging member 14 disposed substantially in thecenter of male member 12 and extending perpendicularly from its surface.Engaging member 14 includes a stem portion 15 and a head portion 16extending from stem portion 15. Head portion 16 has a tapered shape,with the widest part of the taper closest to the stem. Aperture 13 andengaging member 14 are sized and shaped to allow engaging member 14 topass through aperture 13 when female member 11 and male member 12 startfrom a disengaged relationship. Once engaging member 14 has passedthrough aperture 13 such that female member 11 and male member 12 are inan engaged relationship, head portion 15, at the widest part of thetaper, abuts the surface of member 11 surrounding aperture 13. Thusengaging member 14 cannot pass back through aperture 13 in a directionopposite to the direction it passed through initially.

Tissue clip 10 can be made of any suitable material that isbiocompatible, such as polyethylene, teflon, or titanium. However, dueto the high mobility of the LES and the concomitant incidence of implantmigration, it is more preferable to use materials that arebioabsorbable, such as, polydioxanone, poly e-caprolactone, polylacticacid, polyglycolic acid or poly(DL-lactide-co-glycolide), orcombinations or mixtures thereof. When a bioabsorbable material is usedto make tissue clip 10, it is contemplated that eventually adhesionswill form between the tissue on the esophagus wall and the fundus wallsuch that external securing means, such as the clip, are unnecessary.Thus, the bioabsorbable material should be selected such thatdisintegration of the clip occurs after the tissue has had anopportunity to fully adhere.

In general, tissue clip 10 has dimensions that allow it to be used withendoluminal devices and for the purposes of securing the fold createdduring a fundoplication procedure. A preferred form of tissue clip 10has dimensions that prevent ischemia of the tissue between the clipplates while still enabling it to be inserted and installed using aclipping device 20 according to the present invention, which will bediscussed shortly. The plates forming tissue clip 10 each have a lengthof approximately 1 cm and a width of approximately 5 mm. Additionally,engaging member 14 must have a length that enables it to extend throughthe entire thickness of the tissue fold to be secured.

As mentioned previously, tissue clip 10, shown in the embodiment of FIG.2, has an essentially square shape. However, the clip can have othershapes and the male and female members need not have the same shape. Infact, to avoid piercing of the tissue and subsequent migration, it ispreferred to use a clip with rounded corners. Also, the embodiment shownhas only a single aperture and a single engaging member that engage withone another. The scope of the invention includes any number of engagingmembers and apertures to secure the male and female members together.The number may be chosen based on factors such as, for example, theshape of the members, the size of the members, the thickness of thetissue to be folded, the area of the folded tissue to be secured, andother similar factors, and it has been found that two engaging membersand two apertures are preferred to fix the position of the clip and tobetter resist migration.

An embodiment of a clipping device according to the present inventionand adapted for use with the inventive tissue clip described above isshown in FIGS. 3-7. External side, front, and rear views of a clippingdevice 20 are shown in FIGS. 3 a-3 c, respectively. The embodiment ofclipping device 20 generally includes a tube 21 and a tissue clipmagazine 22 on a distal end of tube 21. Tissue clip magazine 22 isconfigured to hold tissue clips 10 during insertion and installation ofthe clips to secure the tissue fold. Tissue clip magazine 22 preferablyhas a substantially hollow semi-circular shape to facilitate insertioninto the cylindrical shape of the esophagus. As shown in FIG. 3 c, aback portion 23 of tissue clip magazine 22 is open so that tissue clipsmay easily be inserted into the magazine. Tissue clip magazine 22 alsoincludes an opening 24 in the top of the magazine so that the fold oftissue can be seated within the magazine during installation of thetissue clip. Tissue clip magazine 22 engages tube 21 such that tube 21lies substantially flush with back portion 23.

FIG. 4 illustrates details of the structure of clipping device 20, asseen from a cross-sectional perspective taken through plane A-A′ in FIG.3 b, looking down toward a base of tissue clip magazine 22. As shown,tube 21 includes three lumens that extend longitudinally through tube21. Specifically, tube 21 includes an endoscope lumen 25 for receivingan endoscope to provide vision into the body during use of clippingdevice 20. A cable lumen 26 also is provided in tube 21 for feeding acable 28 (see FIG. 5) from an actuating mechanism (not shown), such as aspool with a knob to take up the cable, at a proximal end of tube 21 toa pulley-slider track system at the distal end. The third lumen in tube21 is a vacuum supply lumen 27 which is in fluid communication with avacuum source (not shown) at a proximal end of clipping device 20 andwith suction ports 29 disposed on base 30 of tissue clip magazine 22.Sealed ducts (not shown), disposed below base 30, create a fluidcommunication between vacuum supply lumen 27 with suction ports 29.

Tissue clip magazine 22 includes a plurality of stationary holders 31 atbase 30 of the magazine for holding one of the female and male members11, 12 forming the tissue clip. In the embodiment shown in FIG. 4, threestationary holders 31 are disposed at substantially equidistant angularintervals around tube 21. Slider tracks 33 extend radially along base 30from tube 21 to an outer wall 32 of magazine 22. Each slider track 33engages a sliding clip holder 34, shown in FIG. 5 a, at its end oppositeto the end engaging a stationary clip holder 31. As mentionedpreviously, base 30 further includes a plurality of suction ports 29,preferably disposed on both sides of each slider track 33 between tube21 and outer wall 32. The scope of invention is not limited to anyparticular number or arrangement of slider tracks or suction ports. Anynumber or arrangement of slider tracks and ports can be provideddepending on the desired results in securing the tissue fold.

A cross-sectional view taken from the side of clipping device 20 isshown in FIG. 5 a. In this Figure, tissue clips 10 are shown loaded intotissue clip magazine 22. Only one set of tissue clips, clip holders(stationary and sliding), and slider track is shown in FIG. 5 a, howeverthe remaining sets that are not shown are configured and operate in thesame manner. Similarly, due to the perspective of the cross-sectionshown in the Figure, only endoscope lumen 25 and cable lumen 26 areshown. Tissue clips 10 are loaded in magazine 22 with one of the femaleand male members 11 and 12, respectively, engaged with stationary clipholder 31 and the other engaged with sliding clip holder 34. The clipscan be held in pockets created in the clip holders, with the pocketscarrying a plurality of fingers that are configured to form aninterference fit with the tissue clip plates. Preferably, female member11 engages with stationary clip holder 31 and male member 12 engageswith sliding clip holder 34, as shown in the embodiment of FIG. 5 a.Tissue clip magazine 22 preferably has a depth large enough to hold aplurality of tissue clip members stacked on top of each other. In apreferred form of the invention, each pair of clip holders (i.e.stationary clip holder 31 and sliding clip holder 34) holds two tissueclips 10, i.e. two female members 11 disposed one over the other and twomale members 12 disposed one over the other. In the specific embodimentshown, the tissue clip magazine may install six tissue clips in a singleinsertion and actuation of clipping device 20. More or less tissue clipsmay be installed in a single actuation depending on the specificconstruction of the magazine and clip holders.

With reference to FIG. 5 b, the engagement of sliding clip holder 34 andslider track 33 will now be explained. FIG. 5 b is a cross-sectionalperspective of tissue clip magazine 22 and sliding clip holder 34 takenfrom line B-B′ in FIG. 5 a. As shown in FIG. 5 b, sliding clip holder 34includes a narrow portion 38 at its base that is configured to fitsnugly within slider track 33. Preferably, the slider track and thenarrow portion either are made of, or are lined with, materials thatreduce friction between the contacting surfaces to permit smoothmovement of sliding clip holder 34 along slider track 33. Slider track33 opens below base 30 into a channel 36 having a width wider thanslider track 33. A channel-engaging member 39 depends from narrowportion 38 of sliding clip holder 34 and is moveably disposed withinchannel 36. As with slider track 33 and narrow portion 38, preferably,the materials selected for channel 36 and channel-engaging member 39should minimize frictional effects.

Referring again to FIG. 5 a, cable 28 extends from a proximal end ofclipping device 20 through cable lumen 26 to a pulley 35 disposedbetween cable channel lumen 26 and channel 36. From pulley 35, cable 28extends through channel 36 and a connects to channel-engaging member 39.Preferably, cable 28 branches into a plurality of cables, for example,one for each channel. Each of the branched plurality of cables in turnconnects respectively to each of a plurality of pulleys provided in eachchannel. Thus, as an upward force is exerted on cable 28, shown by thevertical arrow in FIG. 6, pulley 35 rotates and the branch of cable 28within channel 36 pulls channel-engaging member 39 through channel 36,imparting motion to sliding clip holder 34 along slider track 33.Channel-engaging member 39 attaches to a spring 37 on a side opposite towhere cable 28 attaches, shown in FIG. 7. Thus, release of the upwardforce on cable 28 causes sliding clip holder 34 to spring back into itsoriginal position near outer wall 32 of tissue clip magazine 22. Femalemembers 11 and male members 12, once secured through the tissue fold toone another, are held together with a force sufficient to cause them tobe released from the interference fit with the fingers of clip holders31 and 34 as the clip holders are pulled away from members 11 and 12.

Using the embodiments of clipping device 20 and tissue clips 10according to the present invention described above, the fundoplicationprocedure is performed in the following manner. Clipping device 20 isloaded with six tissue clips at the three substantially evenly-spacedangular locations around the semi-circle formed by tissue clip magazine22, as described above with reference to FIG. 4. The loaded clippingdevice 20 is then inserted through the esophagus into the stomach.Referring to FIG. 8, an endoscope 40, fed through endoscope lumen 25,provides vision to the stomach so that tissue clip magazine 22 can bepositioned in the region of the fundus to be folded and secured to theesophagus.

During the positioning of tissue clip magazine 22, a vacuum source,connected to vacuum lumen 27, creates a suction at suction ports 29 dueto the fluid communication provided by the ducts as discussed above.With the vision provided by endoscope 40, clipping device 22 is pulledupward toward the region of the fundus wall to be secured. As clippingdevice 22 is pulled upward, the suction provided by suction ports 29draws the fundus wall and the esophagus wall toward base 30 of tissueclip magazine 22. Once these walls have been drawn into tissue clipmagazine 22 to create a tissue fold, an actuating mechanism connected tocable 28 at the proximal end of cable lumen 25 operates to pull cable 28upward. As a result of this force, cable 28, connected tochannel-engaging member 39, pulls member 39 through channel 36, movingsliding clip holder 34 along slider track 33 toward stationary clipholder 31. As sliding clip holder 34 moves toward stationary clip holder31, engaging members 14 eventually pass through apertures 13 to formengaged tissue clips 10 to secure the tissue fold. The force exerted oncable 28 is large enough to enable engaging members 14 to pierce thethickness of the tissue fold and be driven through apertures 13 infemale member 11. The actuating mechanism provided to create the upwardforce on cable 28 can be a handle that is turned manually, an automaticwinding reel, or other suitable like actuators known to those skilled inthe art.

After clipping device 20 has been actuated and tissue clips 10 have beenformed, a tissue fold secured at angular positions around the esophagusresults, as shown in FIG. 9. The uniform depth of tissue clip magazine22, and the uniform spacing (both radially and vertically) of tissueclips 10, results in a tissue fold that is secured uniformly and quicklyin a single insertion of the endoluminal device.

After tissue clips 10 have been installed, the force on cable 28 isremoved and sliding clip holders 34 spring back into their originalposition, releasing male members 12. Clipping device 20 can then beremoved from the stomach. Tissue clips 10 remain to secure the funduswall to the esophagus wall preferably until natural adhesion of the twotissues occurs. A sclerosing agent can be injected onto the tissue foldto facilitate the natural adhesion process. Eventually and preferably,tissue clips 10 disintegrate and fall away from the naturally-adheredfold.

It will be apparent to those skilled in the art from consideration ofthe specification and practice of the invention disclosed herein thatvarious modifications and variations can be made in both the tissue clipand the clipping device of the present invention. For example, thetissue clip, and the tissue clip magazine for holding the tissue clip,may be provided in different sizes, such as, for example, small, medium,and large, for use with children, average-sized, and larger patients,respectively. However, it is important that the entire device beconfigured to fit in the esophagus, or other part of the body, dependingon the particular endoluminal procedure being performed. Additionally,the number of tissue clips used to secure the tissue fold may be alteredand the tissue clip magazine may be altered accordingly to house adifferent number of clips in both the radial and vertical directions. Inaddition, additional lumens may be provided in the tube so thatadditional devices may be inserted onto the esophagus and stomach toperform additional operations.

The particular use of both the tissue clip and the clipping device inconjunction with a Nipple Fundoplication procedure is illustrative only.It is considered to be within the scope of this invention to use thesedevices with other endoluminal procedures, as well as for purposesoutside of the medical industry that may require insertion andinstallation of fasteners through small spaces.

Therefore, the invention in its broader aspects is not limited to thespecific details and illustrative examples shown and described in thespecification. It is intended that departures may be made from suchdetails without departing from the true spirit or scope of the generalinventive concept as defined by the following claims and theirequivalents.

What is claimed is:
 1. A method of reconfiguring the fundus of astomach, comprising: delivering an instrument into a patienttransorally, the instrument including an elongated tube and a distalmember disposed on a distal end portion of the tube; suctioning aportion of tissue of the fundus into an opening of the distal member tocreate a fold of tissue having a first exterior surface portion oftissue in contact with a second exterior surface portion of tissue;extending a fastener through the tissue fold such that the fastenerpasses through the first and second exterior surfaces to fasten thetissue fold.
 2. The method of claim 1, wherein the tissue fold furtherincludes a portion of the esophagus wall.
 3. The method of claim 2,further including extending the fastener through the portion of thefundus before extending the fastener through the portion of theesophagus wall.
 4. The method of claim 1, wherein the fastener isbioabsorbable.
 5. The method of claim 1, wherein the fastener includes amale member and a female member configured to engage one another.
 6. Themethod of claim 1, further including extending a plurality of fastenersthrough the tissue fold such that each fastener passes through the firstand second exterior surfaces to fasten the tissue fold.
 7. The method ofclaim 1, further including simultaneously extending a plurality offasteners through the tissue fold such that each fastener passes throughthe first and second exterior surfaces to fasten the tissue fold.
 8. Themethod of claim 1, further including suctioning the portion of tissue ofthe fundus into the opening of the distal member via a plurality ofsuction ports.
 9. A method of reconfiguring the fundus of a stomach,comprising: delivering an instrument into a patient transorally, theinstrument including an elongated tube and a distal member disposed on adistal end portion of the tube; suctioning a portion of tissue of thefundus into an opening of the distal member to create a fold of tissuehaving a first exterior surface portion of tissue in contact with asecond exterior surface portion of tissue; extending a plurality offasteners through the tissue fold such that each fastener passes throughthe first and second exterior surfaces to fasten the tissue fold. 10.The method of claim 9, wherein the tissue fold further includes aportion of the esophagus wall.
 11. The method of claim 10, furtherincluding extending the fastener through the portion of the fundusbefore extending the fastener through the portion of the esophagus wall.12. The method of claim 9, wherein the fastener is bioabsorbable. 13.The method of claim 9, wherein the fastener includes a male member and afemale member configured to engage one another.
 14. The method of claim9, further including simultaneously extending the plurality of fastenersthrough the tissue fold.
 15. The method of claim 1, further includingsuctioning the portion of tissue of the fundus into the opening of thedistal member via a plurality of suction ports.
 16. A method ofreconfiguring the fundus of a stomach, comprising: delivering aninstrument into a patient transorally, the instrument including anelongated tube and a distal member disposed on a distal end portion ofthe tube; suctioning a portion of tissue of the fundus and a portion oftissue of an esophagus wall into an opening of the distal member tocreate a fold of tissue having a first exterior surface portion oftissue in contact with a second exterior surface portion of tissue;extending a fastener through the tissue fold such that the fastenerpasses through the first and second exterior surfaces to fasten thetissue fold.
 17. The method of claim 16, further including extending thefastener through the portion of the fundus before extending the fastenerthrough the portion of the esophagus wall.
 18. The method of claim 16,wherein the fastener is bioabsorbable.
 19. The method of claim 16,wherein the fastener includes a male member and a female memberconfigured to engage one another.
 20. The method of claim 16, furtherincluding extending a plurality of fasteners through the tissue foldsuch that each fastener passes through the first and second exteriorsurfaces to fasten the tissue fold.